MAUDE Adverse Event Report: US ENDOSCOPY SMARTBAND LIGATION KIT

Model Number	SLK-6
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that when applying the second band of their smartband multi-band ligation kit, the band failed to deploy onto the varix and was sitting in the esophagus.The user facility was able to quickly retrieve the band and successfully deploy a third band on the varix.No report of injury or procedure delay.
Additional Manufacturer Narrative
Investigation of the reported event is in progress; a follow-up report will be submitted when additional information becomes available.Udi related data clarification, a follow-up mdr will be submitted with the udi identifiers once the device information is confirmed.
Additional Manufacturer Narrative
The device subject of the reported event was not returned to steris for evaluation.Without the return and evaluation of the product, the cause of the event could not be determined.Through follow up with the user facility personnel, steris learned it was stated that the smartband multi-band ligation kit subject of the reported event had already expired, prior to use.Steris offered in-service training on the proper use and operation of the device; however, the user facility declined.No additional issues have been reported.

• Brand Name: SMARTBAND LIGATION KIT
• Common Device Name: LIGATION KIT
• Manufacturer (Section D): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer (Section G): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4403586251
• MDR Report Key: 23879035
• Report Number: 1528319-2025-00115
• Device Sequence Number: 11954969
• Product Code: MND
• UDI-Device Identifier: 00850261006019
• UDI-Public: (01)00850261006019(11)221104(17)240818(10)4768360
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/18/2024
• Device Model Number: SLK-6
• Device Catalogue Number: IE11002
• Device Lot Number: (10)4768360
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/04/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown